Randolph Engineering, Inc.
Country not established FDA establishment FEI 1293762
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
What Randolph Engineering, Inc. makes
Randolph Engineering, Inc. makes tinted non-prescription spectacles and optical inserts for chemical-biological masks, such as the M-17 mask insert.
These devices are classified as Class I medical devices and are listed in the FDA 510(k) and FDA UDI registries. The company is based in the United States.
Catalogue
Insert, Optical, Chemical-Biological Mask, M-17 Ref K872607
510(k) 510(k)
Company details
- FDA FEI number
- 1293762
- Address
- 26 THOMAS PATTEN DR, RANDOLPH, MA, 02368
Frequently asked questions
How many devices does RANDOLPH ENGINEERING, INC. have in the registry?
The registry currently lists 1 device for RANDOLPH ENGINEERING, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list RANDOLPH ENGINEERING, INC.'s devices?
Among its 1 most recently registered device, RANDOLPH ENGINEERING, INC. has devices listed in FDA 510(k) (1 device).
What risk classes do RANDOLPH ENGINEERING, INC.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for RANDOLPH ENGINEERING, INC.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from RANDOLPH ENGINEERING, INC. in the registry?
The most recently registered devices listed for RANDOLPH ENGINEERING, INC. include INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17.